Safety and Efficacy Study to Treat Bacterial Vaginosis

Phase 3

Completed

• Conditions: Bacterial Vaginosis
• Interventions: Drug: Placebo Vehicle (non-treatment); Drug: Product 55394

• Registration Number: NCT01621399
• Lead Sponsor: Medicis Global Service Corporation

Brief Summary

The purpose of this study is to determine if product 55394 is safe and efficacious for the treatment of bacterial vaginosis.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-06-14
• Study First Submitted QC: 2012-06-15
• Study First Posted: 2012-06-18
• Primary Completion: 2012-10
• Study Completion: 2012-12
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-20
• Last Update Posted: 2013-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 651

Inclusion Criteria

• Have a clinical diagnosis of bacterial vaginosis as determined by the investigator.
• Other items as identified in the protocol.

Exclusion Criteria

• Have a known or suspected other infectious cause of vulvovaginitis.
• Other items as identified in the protocol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle	Placebo Vehicle (non-treatment)	Treatment with the vehicle (placebo)
Product 55394	Product 55394	Treatment with product 55394

Primary Outcome Measures

Name	Time	Method
Clinical Cure	Day 21	The proportion of subjects with a clinical cure at the Day 21 visit, as assessed by the investigator.

Secondary Outcome Measures

Name	Time	Method
Therapeutic Cure	Day 21	The proportion of subjects with a therapeutic cure at the Day 21 visit. Therapeutic cure is defined as both a clinical cure and bacteriological cure as assessed by the investigator and the central laboratory, respectively.